MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	85060
Medical Device Problem Codes	Positioning Problem (3009); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a blazer ii htd was used in a paroxysmal supraventricular tachycardia procedure.During the procedure it was noted that the distal tip temperature was not stable.The procedure was completed with another blazer with no patient complications being reported.
Event or Problem Description
It was reported that a blazer ii htd was used in a paroxysmal supraventricular tachycardia procedure.During the procedure it was noted that the distal tip temperature was not stable.The procedure was completed with another blazer with no patient complications being reported.
Additional Manufacturer Narrative
The returned device was reported for distal tip temperature being unstable.The returned device passed all visual and functional testing.The electrical and continuity tests and showed no evidence or defects that could have contributed to the reported event.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.There is no evidence that the device was used in a manner inconsistent with the labelled indications.

• Brand Name: BLAZER II HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10561161
• Report Number: 2134265-2020-13058
• Device Sequence Number: 2822606
• Product Code: LPB
• UDI-Device Identifier: 08714729172055
• UDI-Public: 08714729172055
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: 85060
• Device Catalogue Number: 85060
• Device Lot Number: 0025529510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1
• Patient Age: 49 YR